Kornimate/medical-research-clean huggingface dataset:
the comparison of tacrolimus and sirolimus immunosuppression based drug regimens in kidney transplant recipients

Conditions: Kidney Diseases

Summary: this study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

the aim of this study was to compare the complete avoidance of calcineurin inhibitors (ci) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. this study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. all patients received antithymocyte globulin induction. all rejection episodes were proven by biopsy. the hypothesis was that ci free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (gfr) at one year after kidney transplantation.

Eligibility criteria:
inclusion criteria: * living and deceased donor kidney transplant recipients at the mayo clinic, rochester, minnesota exclusion criteria: * patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant * pediatric patients (\<18 years of age) * multi-organ transplants (e.g., kidney-pancreas, kidney-liver) * abo-incompatible or positive crossmatch recipients (abo incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.) * patients with severe hyperlipidemia (serum cholesterol \>350 mg/dl or serum triglycerides \>500 mg/dl * patients with severe leukopenia (white blood cell count \[wbc\]\<3000 10\^3/ml) * patients unwilling to return to the transplant center for late follow-up visits * body mass index (bmi) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon

Keywords: kidney transplantation immunosuppression calcineurin inhibitor sirolimus chronic allograft nephropathy
attention and visual perception in schizophrenia: a functional magnetic resonance imaging (fmri) study

Conditions: Schizophrenia

Summary: the main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. processing visual information involves both automatic grouping processes and control processes. automatic grouping processes allow the building of a global configuration from local contour information. it is necessary in order to recognize objects. control processes allow tending to and prioritizing information parts. the paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. it is adapted to fmri in order to explore the neurobiological basis of the deficits. the investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.


Eligibility criteria:
inclusion criteria: * patients with schizophrenia (dsm-iv criteria) * healthy controls matched with patients on age, sex and education level * ages 18 to 50 * signed informed consent * right-handed exclusion criteria: * no severe somatic illness * no invalidating sensory disease * no drug abuse, as defined by dsm-iv criteria * no general anaesthesia in the past 3 months * no intake of drugs affecting the cns, except for patients

Keywords: fmri visual perception attention
identification of new colorectal cancer genes

Conditions: Colorectal Cancer

Summary: the purpose of this study is to define new genes for family risks of developing colon cancer.

colorectal cancer is one of the most significant causes of cancer morbidity and mortality in the united states. in 1997, approximately 130,000 men and woman were diagnosed with colorectal cancer (fourth most common cancer site) and approximately 55,000 died of this disease (second most common cause of cancer deaths); (cancer facts \& figures, 1997). genetic factors clearly contribute to the etiology of colorectal cancer. because there is evidence to suggest genetically determined susceptibility to colorectal cancer exists in a proportion of newly diagnosed cases each year, we are conducting a study to identify new genes that are associated with an increased susceptibility to familial colorectal cancer by analysis of families with a clustering of colorectal cancers.

Eligibility criteria:
inclusion criteria: * age 18 years or greater * able to provide informed consent * any family in which a minimum of two first-degree relatives either are, or have previously been, affected with primary colorectalcancer. these "minimum inclusion criteria" must be met within three generations of the proband or kindreds in which colorectal cancer and lymphoma or renal cell cancer are present or in kindreds in which lymphoma alone or lymphoma and renal cell cancer are present exclusion criteria: * age less than 18 years * family not at increased risk for familial colorectal cancer (see section 4.1) * family with a hereditary polyposis syndrome (e.g. classic fap) * not able to provide informed consent

Keywords: colorectal cancer genetic testing genetic mutations
outcomes with fractional flow reserve in chronic coronary syndrome

Conditions: Chronic Coronary Syndrome

Summary: the use of fractional flow reserve (ffr) to assess the functional relevance of coronary stenoses has been demonstrated to reduce the risk urgent revascularization in chronic coronary syndrome patients.\[1\] the goal of this study is to assess whether the utility of using ffr during percutaneous coronary intervention (pci) in chronic coronary syndrome patients is confirmed in a real-life scenario. this study will implement a regression discontinuity design (rdd). rdd is a quasi-experimental study design able to provide robust findings on causality using observational data.

all patients in this study were included in the swedish coronary angiography and angioplasty registry (scaar), a sub-registry of swedeheart. \[2\] data regarding ffr assessments are documented in scaar in terms of ffr values and coronary segments investigated with ffr. the use of ffr during pci is left at the discretion of the operator. since a nondeterministic assignment to revascularization is expected at the cut-off, a fuzzy rdd design will be used in the analyses. moreover, ffr values equal to 0.80 (at the cut-off) will be excluded from the analysis since treatment assignment exactly at the cut-off may substantially vary across operators and this may create distortions in the treatment discontinuity. local linear regression estimates with kernel triangulation and asymmetric bandwidth selection will be used in the analysis. bandwidth selection will be based on a fully data-driven approach that minimizes the bias-variance trade-off.\[3\] estimates from rdd will be presented as risk differences \[rd\] complemented by 95% robust confidence intervals.\[4\]

Eligibility criteria:
inclusion criteria: * chronic coronary syndrome undergoing coronary angiography and ffr measurement * swedish personal identification number exclusion criteria: * previous coronary artery bypass grafting * left main disease or undergoing ffr/pci of left main * ivus/oct use * diffuse disease (≥ 2 segments treated in a same vessel investigated with ffr, ≥ 2 segments investigated with ffr in a same vessel) * pci in a distal segment with respect to ffr measurements

Keywords: percutaneous coronary intervention fractional flow reserve
repurposing atovaquone for the treatment of platinum-resistant ovarian cancer

Conditions: Ovarian High Grade Serous Adenocarcinoma; Platinum-Resistant Ovarian Carcinoma

Summary: this phase ii trial test tests how well repurposing atovaquone works in treating patients with platinum-resistant ovarian cancer. atovaquone is used for the treatment or prevention of certain infections. atovaquone is in a class of medications called antiprotozoal agents. it works by stopping the growth of certain types of protozoa that can cause pneumonia. giving atovaquone may be effective in treating platinum-resistant ovarian cancer and result in improved outcomes compared to standard chemotherapy regimens.

primary objective: i. to determine progression free survival of twenty-eight patients with platinum-resistant ovarian cancer treated with atovaquone. secondary objectives: i. to determine clinical benefit rate (complete response, partial response or stable disease) at six months. ii. to determine overall survival. iii. to quantitate the on-target stat3 inhibitory effect of atovaquone on stat3-dependent gene transcription. iv. to quantitate changes of the tumor immune infiltrate by inhibition of stat3 with atovaquone. outline: patients receive atovaquone orally (po) on study. patients also undergo computed tomography (ct) and biopsy or paracentesis throughout the study. after completion of study treatment, patients are followed up for 30 days and then every 6 month thereafter.

Eligibility criteria:
inclusion criteria: * patients with platinum-resistant, high-grade serous ovarian cancer, defined as disease progression within six months of completion of their last platinum-based chemotherapy * patients must maintain eastern cooperative oncology group (ecog) performance status of 0 or 1 * there will be no limitations on number of prior lines of therapy * trial is open to non-english speaking patients * trial is open to patients referred from community practice exclusion criteria: * patients who are \< 18 years old * patients who are pregnant or breastfeeding (due to cancer of their reproductive organs, patients enrolled in the trial are unable to conceive) * patients who are incarcerated * patients who are unable to provide consent / lack decision-making capacity
combination of cryosurgery and nk immunotherapy for advanced breast cancer

Conditions: Breast Cancer Recurrent

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to advanced breast cancer.

by enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (nk) cells for advanced breast cancer. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: breast cancer cryosurgery nk immunotherapy
no donors and inhibitors to study imbalance of nitrogen stress and antioxidant defense in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary aim of this study is to investigate the effects of oral and inhaled administration of l-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled no and no metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with copd.

nitric oxide (no) is produced by resident and inflammatory cells in the respiratory tract by the enzyme no synthase (nos), which exists in three isoforms: neuronal nos (nnos), inducible nos (inos), and endothelial nos. no production is increased in patients with copd, and the production of no under oxidative stress conditions generates reactive nitrogen species that may amplify the inflammatory response in copd.

Eligibility criteria:
inclusion criteria: * healthy non-smokers * normal spirometry (fev1 \>90 % predicted; exhaled no bigger than or equal to 10 ppb; flow 50 ml/s) * at risk (current smokers) * normal spirometry, with or without chronic symptoms (cough, sputum production) * fev1 reversibility of \<15% after inhaled beta2-agonists\* * moderate copd * fev1 greater than or equal to 30% and \< 80% * fev1/fvc \< 70% predicted * fev1 reversibility of \<15% after inhaled beta2-agonists * with or without chronic symptoms (cough, sputum production, dyspnea) * able to comprehend and grant a written informed consent exclusion criteria: * concomitant use or pre-treatment within the last 4 weeks with oral steroids * respiratory infection within 4 weeks prior to entry into the trial * females who are pregnant or lactating * history of current or past drug or alcohol abuse

Keywords: copd aminoguanidine nitric oxide
effects of echinacea in children

Conditions: Upper Respiratory Infections

Summary: the goal of the this study is to determine if echinacea purpurea stimulates the immune system in children. for the study, 40 healthy children, 6-11 years old will be randomized to receive echinacea purpurea or placebo for 10 days in 3 consecutive months. blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. markers of immune activity in children receiving echinacea or placebo will be compared.

this is an application to study the biologic activity of a specific formulation of echinacea purpurea in children 6-11 years old. the goal of the study is to determine if echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (tnf), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (il-2, il-6, and il-12), as well cd25 and cd69 activation. a total of 40 study children will be randomized to receive either the echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. blood samples will be obtained at baseline, at the time of "peak" tnf activity, and either 30 or 120 days after beginning the study medication. prior to beginning this pediatric study "peak" tnf activity will be determined by administering the echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. if it is demonstrated that this formulation of e purpurea has biologic activity, a large randomized controlled trial is planned to determine if e purpurea can prevent upper respiratory tract infection (uri) in children 2-11 years old.

Eligibility criteria:
inclusion criteria: * healthy children 6-11 years old * parent/caregiver who can read and speak english * one child per family exclusion criteria: * history of allergic reaction to echinacea or related species * history of asthma * history of allergic rhinitis * history of autoimmune disease

Keywords: upper respiratory tract infections children echinacea prevention immune modulation
physical condition and self-efficacy in people with fall risk

Conditions: Fall Risk

Summary: middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. this program consisted on an adapted exercise program. two sessions per week were performed, during 6 weeks supervised by a physiotherapist. at the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.


Eligibility criteria:
inclusion criteria: * fall risk (morse scale) exclusion criteria: * had no capacity to walk independently

Keywords: physical condition self-efficacy fall risk exercise program
fructose-induced palmitate synthesis in overweight subjects

Conditions: Elevated Triglycerides; Diabetes; Cardiovascular Disease

Summary: dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. in a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum vldl triglyceride palmitate made by the liver from each single oral dose of fructose (0.5 g/kg), fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). our hypotheses are that the synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose and 2) show a dose-response. the lipogenic responses will be compared and correlated with markers of carbohydrate and lipid flux measured after fasting and post-fructose. the results will serve as a guide to the development of a new outpatient probe of the de novo lipogenic pathway in subjects who vary in their lipogenic response to oral fructose. these studies should ultimately yield valuable new information about the mechanisms linking dietary carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.


Eligibility criteria:
inclusion criteria: * males and females, 18-75 years of age * body mass index (bmi) 25-35 and within 10% of maximum weight * willing and able to stop fish oil, psyllium, other non-prescribed vitamins/supplements for 1 week prior to study until completion of study * willing to not drink alcohol for 24 h before each day of blood sampling exclusion criteria: * diabetes or other endocrine disorder, hepatitis or other liver disorder, hiv, or autoimmune disease * medication(s) known to affect lipids, including hormonal contraceptives * recent acute illness * gastrointestinal disease resulting in significant gi dysfunction or malabsorption * history of fasting tg \>800 mg/dl * history of ethanol abuse (current intake \>2 drinks/d) or illicit drugs * history of severe psychiatric illness * if female, pregnant or breastfeeding * participation in an investigational drug study within one month of screening * unusual diet or extreme level of physical activity * have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

Keywords: elevated triglycerides diabetes cardiovascular disease
randomized, controlled trial of hyperosmotlar saline for rotator cuff repair irrigation solution

Conditions: Arthroscopic Shoulder Surgery; Rotator Cuff Tear

Summary: the goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. it will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. this study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. this knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. the main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period.


Eligibility criteria:
inclusion criteria: age \> 18 years of age patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears exclusion criteria: patients younger than 18 years of age patients who are pregnant, mentally disabled, or imprisoned patients not receiving inter-scalene nerve block (catheters excluded) patients undergoing labral repair, capsular release, or distal clavicle excision patients with irreparable rotator cuff tears patients receiving any repair augmentation or graft patients with a known hypersensitivity to sodium lacta
conventionally vs. digitally fabricated complete dentures: clinical treatment outcome differences

Conditions: Mouth, Edentulous

Summary: purpose: to compare complete denture outcomes between conventional and digital denture fabrication processes. participants: sixteen edentulous adult patients in the university of north carolina school of dentistry student clinic who are seeking removable complete dentures. procedures (methods): two complete sets of dentures will be fabricated for each subject: one using the conventional process (a) and the other using a digital process (b). variability will be assessed by the research team, the treating dental students, an independent prosthodontist, and the patients through quantitative measures. case selection and results analysis will be evaluated with recognition of the prosthodontic diagnostic index.

rationale for study design an ab/ba (conventional=a, digital=b) crossover design with no wash-out period is flawed for this study, and its weakness is the potential for a carryover effect (benefits or risks associated with treatment a carry over to treatment b). a wash-out period is not feasible for this study because it would require the patient-subjects to suspend use of their dentures for the duration of the wash-out period. the investigators have decided to conduct the study using the abb/baa crossover design, which does not require a wash-out period and will permit testing and discounting of a possible carryover effect. in addition, this design is more appropriate for a small sample size than the ab/ba design. the investigators are adding to the scant literature on digital dentures, information that has never before been studied - the retention, aesthetics, and stability of digital dentures compared to conventional dentures. additionally, the investigators will have longitudinal data on these characteristics regarding digital dentures. if the functional assessment of dentures (fad) and the patient evaluation show positive results for the digital dentures, this could lead to increased use of the computer -aided design/ computer -aided manufacturing (cadcam) fabrication method which, in turn, would allow greater numbers of people to benefit from the advantages of the digital dentures as described earlier in this application (e.g., a better fit, fewer visits with less time in the chair, less biofilm formation, etc.)

Eligibility criteria:
inclusion criteria: 1. unc school of dentistry student clinic patients requiring maxillary and mandibular complete dentures 2. ages 18 to 99, inclusive 3. able to read, speak, and understand english 4. without natural tooth or implant supported overdentures 5. edentulous in both jaws for at least 6 months 6. any prosthodontic diagnostic index (pdi) type with a preference given to types 1-3 exclusion criteria: 1. non-registered patient in unc school of dentistry student clinics 2. patient not able or unwilling to give consent 3. subject had extractions within last 6 months